Efficacy and Safety of FG-4592 for Treatment of Anemia in Patients With Lower Risk MDS With Low Red Blood Cell Transfusion Burden



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Anemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:September 7, 2017
End Date:March 2019
Contact:Charles Bradley, PhD
Email:082MDSstudy@fibrogen.com
Phone:1-415-978-1672

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A Phase 3 Randomized Double-Blind Placebo-Controlled Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Patients With Lower Risk Myelodysplastic Syndrome (MDS) With Low Red Blood Cell (RBC) Transfusion Burden (LTB)

The purpose of this study is to determine whether FG-4592 is safe and effective in the
treatment of anemia in patients with Lower Risk Myelodysplastic Syndrome and Low Red Blood
Cell Transfusion Burden.

This study includes an Open-Label and a Double-Blind component. In each, there is an up to 28
days screen period followed by a treatment period of 52 weeks and a 4 week end of treatment
assessment.

Key Inclusion Criteria:

- Diagnosis of primary MDS classified as very low, low or intermediate risk with <5%
blasts. There is no minimum time from diagnosis except to allow for proper IPSS-R
classification to be made, and to show transfusion dependence.

- RBC transfusion of either 2-4 pRBC units over the 8 weeks prior to randomization or 1
pRBC in two consecutive periods of 8 weeks within the 16 weeks prior to randomization

- No restriction on prior use of ESAs, except no ESA use within 8 weeks prior to
registration/randomization

- Pre-transfusion hemoglobin of <= 10 g/dL,

- ECOG of 0-2 at screen

- History of cured malignancy with no evidence of recurrence for a least 3 years are
eligible

Key Exclusion Criteria:

- Diagnosis of secondary MDS

- Significant myelofibrosis (>2+fibrosis)

- MDS associated with 5q(del) abnormality

- Screen serum erythropoietin level > 400 mIU/mL,

- Clinically significant anemia due to non-MDS etiologies
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